05 March 2021
MTPConnect is pleased to bring you our March seminar series webinar - “Adaptive regulation for digital health technologies - a pathway for industry” - on 24 March, 1pm-2:00pm.
Digital health technologies (DHTs) have the potential to disrupt both the medical technology, biotechnology and pharmaceutical sector and the broader delivery of healthcare, creating challenges for the effective and timely regulation of new therapeutic goods.
Join us for this seminar as we embark on the journey that a digital medical technology company takes to commercialise their product. It’s a world which is rapidly evolving for digital medical devices and also highly regulated. Hear about Australian companies who are working within the regulatory framework to develop their innovations.
MTPConnect recently released a new report 'Adaptive Regulation for Digital Health: Enhancing Australia’s Regulation System' that examines how digital health industry stakeholders are engaging with the Australian therapeutic goods regulatory framework, and focuses on research into DHTs regulated as medical devices – including software as a medical device (SaMD) and physical medical devices with associated software.
Moderated by Dr Lisette Pregelj from the University of Queensland, who co-authored MTPConnect’s report, we are delighted to host expert guests for the session.
CSIRO Health and Biosecurity is working with CSIRO's Australian Animal Health Laboratory (AAHL) in addressing these
challenges and the integration of multiple disciplines working to achieve optimal health for people, animals, plants, the economy and environment. Dr Rob Grenfell, a Public Health Physician, is the Director of CSIRO’s Health and Biosecurity Business Unit and leads a broad portfolio covering Nutrition, eHealth, Medtech and Diagnostics and Biosecurity.
Cardihab™ is a digital health company (a CSIRO spin-off) that exists to help patients reach optimal health when at risk of, or living with, heart disease – giving patients flexibility to complete supervised cardiac rehabilitation using a smartphone app which connects with a secure clinician portal. Cardihab’s CEO Helen Souris will join the session to share their approach to adaptive regulation.
ANDHealth provides programs designed specifically to address the unique commercialisation challenges faced by digital health companies and CEO & Managing Director Bronwyn Le Grice will discuss the importance of building in an adaptive regulatory framework to strategic business plans.
We hope you can join us, register here.